AP-1
Overview of Janssen’s Single-Dose COVID-19 Vaccine, Ad26.COV2.SJanssen Pharmaceutical Companies of Johnson & Johnson
US Centers for Disease Control and PreventionAdvisory Committee on Immunization Practices February 28, 2021
AP-2
Introduction
Macaya Douoguih, MD, MPH Head of Clinical Development and Medical AffairsJanssen Pharmaceuticals Companies of Johnson & Johnson
AP-3
Phase 3 study enrolled > 44,000 participants and was conducted during height of pandemic
Offers substantial protection, especially against severe COVID-19 including hospitalization and death, irrespective of variant
Well-tolerated and safe Single-dose regimen with storage, transportation conditions
compatible within existing distribution channels
Janssen’s Vaccine Candidate (Ad26.COV2.S) Supports Global Effort to Fight COVID-19
AP-4
85% vaccine efficacy* against severe COVID-19 globally, including the United States• Consistent vaccine efficacy against severe disease across all regions• Equally high protection in South Africa (n > 6,500) where B.1.351 is highly prevalent (> 95%)• Complete protection against COVID-19 related hospitalizations as of day 28 and no COVID-19 related
deaths in the Ad26 group compared to 5 in the placebo group
Key Efficacy Findings from Ad26.COV2.S Single-Dose Study Demonstrate Protection Against Symptomatic COVID-19
*> Day 28
66% vaccine efficacy* against moderate to severe/critical COVID-19 across all countries• Protection as of 2 weeks after vaccination
72% vaccine efficacy* against moderate to severe/critical COVID-19 in the United States • Participants reflected diversity of US population (n > 19,000)
Similar vaccine efficacy demonstrated by age, comorbidities status, sex, race,and ethnicity
AP-5
Vaccine Efficacy (VE) Results Support Protection Against Emerging Variants
Trial conducted in areas where COVID-19 incidence was highest and where variants were emerging
% variant95% B.1.351 lineage
3% D614G
% variant69% P.2 lineage
31% D614G
% variant96% D614G
3% CAL.20C
COV3001 site locationsCountries with emerging variants
United States86% VE severe/critical
Brazil88% VE severe/critical 82% VE
severe/critical
South Africa
VE based on total dataset, including non-centrally PCR confirmed cases
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Logistical, Practical Advantages to Help Simplify Distribution and Expand Vaccine Access of Single Dose Ad26.COV2.S
Prepared forlarge-scale
manufacturing
20 million doses by end of March
100 million doses to US in
first half of 2021
Single, 0.5ml dose offers ability
to vaccinate population faster
5 doses per vial
No dilution required
Stored for 3 months at
normal refrigerator
temperatures, 2° to 8° C
(36° to 46° F)
Shipping fits into existing supply chain infrastructure
2-year shelf life when frozen, -25° to -15° C(-13° to 5° F)
AP-7
Substantial Experience with Adenovirus 26-based Vaccines
• Local, systemic reactogenicity in line with other licensed vaccines
• Database searches for AESIs revealed no safety signals
• Across continents• Healthy adults• Elderly > 65 years• Breastfeeding, pregnant women within Ebola program
• Various races, ethnicities• Infants ≥ 4 months• People with HIV
Substantial clinical experience with Ad26-based vaccines(N > 193,000)
Regular database reviews show good tolerability, safety
AESIs: Adverse Events of Special Interest
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Comprehensive Development ProgramKey Studies
Preclinical Animal Studies
Including non-human primate (NHP) studies Immunogenicity, efficacy
Phase 1/2aCOV1001
First in Human (FIH) studySafety, immunogenicity, and dose selection
Phase 2 COV2001
Lower dosing and different intervalsSafety, immunogenicity in adolescents and adults
Phase 3COV3001
(ENSEMBLE)
Focus of EUA, single-dose pivotal studyEfficacy, safety, and immunogenicity
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COV3009: two-dose regimen Phase 3 efficacy study Results estimated to be available late this year
Immunogenicity and safety studies in children, 0 – 17 years Adolescent study will open enrollment soon
Pregnant women Planned to begin late March/early April 2021
Immunocompromised individuals Planned to begin Q3 2021
Post-authorization observational studies Including pregnancy exposure registry
Additional Key Studies
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Vaccine Design and Immunogenicity
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Janssen Ad26 vector can not replicate in the human body
Cell line grows in medium free of animal components
Vial of Ad26-based vaccine contains buffer with commonly used ingredients in vaccines No adjuvants, no antibiotics, no preservatives
Ad26 Vector is Replication Incompetent
ΨAdenovirus genome
Transgene
E1 E3
Replication Incompetent Vaccine Vectors
Complementing Cell Line
vector
AP-12
Ad26.COV2.S Expresses SARS-CoV-2 Spike Protein, Eliciting Multiple Immune Responses
I.M. injection of
Ad26.COV2.S HUMAN CELL
Transgene expression
Spike protein
Adenoviral vectors
classified as non-integrating*
*FDA Guidance, 2020
Ad26.COV2.S
CELLULAR IMMUNITYCytotoxicCD8+ T cell
CD8+ T cell
B cell
CD4+ T cell
APC
APC
HUMORAL IMMUNITYSpike-specific Antibodies
Plasma cellLYMPH NODE
AP-13
Protection against viral replication Near complete protection in nose Full protection in lung Durability > 6 months Protection seen even with 4-fold lower vaccine dose
Nearly full protection in aged NHP Protection in Syrian golden hamsters, no VAED
Results met FDA criteria to progress to human clinical trials
Single-Dose Ad26.COV2.S Fully Protects Against SARS-CoV-2 Challenge in Non-Human Primates (NHP)
VAED = Vaccine Associated Enhanced Disease
AP-14
Neutralizing antibody titers elicited in 96% of adults, independent of age Titers detected as early as 14 days post vaccination Increased to Day 57 and maintained thereafter
Strong CD8+ and Th1 dominated CD4+ T cell responses Minimizes risk for vaccine associated enhanced disease (VAED)
Both doses had favorable safety profile Lower dose more favorable reactogenicity profile
Ad26.COV2.S 5x1010 vp dose selected for COV3001
Summary of Phase 1/2 Immunogenicity Data Following Single Dose of Ad26.COV2.S
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Phase 3 Study COV3001 (ENSEMBLE) Efficacy and Safety
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COV3001: Randomized, Double-Blind, Phase 3 Trial
A d 2 6 . C O V 2 . S ( 5 × 1 0 1 0 vp )
P l a c e b o ( s a l i n e )
Randomized ReceivedInjection
Evaluating efficacy, safety, immunogenicity of single dose of Ad26.COV2.S
Randomization stratified by site, age group, and absence / presence of comorbidities
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COV3001: Began Enrollment with Safety Run-in Phase
Stage 1a safety run in
• ~2,000 adults 18 – 59 years without comorbidities
Stage 1b initiated following DSMB review of 1a data
• Adults 18 – 59 years with and without comorbidities
Stage 2a safety run in
• ~2,000 adults ≥ 60 years without comorbidities
Stage 2b initiated following DSMB review of 2a data
• Adults ≥ 60 years with and without comorbidities
Study targeted at least 30% of total study population to be ≥ 60 years
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COV3001: Co-Primary Endpoints
Per Protocol Population
at least 28 days after vaccination
at least 14 days after vaccinationVaccine efficacy to prevent moderate to severe/critical
COVID-19
Primary Hypothesis: lower limit of 95% confidence interval > 30%
AP-19
RT-PCR or molecular test confirmation of SARS-CoV-2 infectionAND
At any time during observation period:
COV3001: Case Definition for Moderate COVID-19
≥ 2 new or worsening sign or symptoms≥ 1 new or worsening sign or symptom
OR
Respiratory rate ≥ 20 bpm Abnormal oxygen saturation
(> 93% on room air) Evidence of pneumonia Deep vein thrombosis (DVT) Shortness of breath
Fever Heart rate ≥ 90 bpm Shaking chills Muscle pain Changes to olfaction or taste Gastrointestinal symptoms Red or bruised feet or toes
Malaise Headache Cough Sore throat
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RT-PCR or molecular test confirmation of SARS-CoV-2 infectionAND
At any time during observation period:
COV3001:Case Definition for Severe/Critical COVID-19
≥ 1 of these signs or symptoms Clinical signs indicative of severe systemic illness: Respiratory rate ≥ 30 bpm,
heart rate ≥ 125 bpm, SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300 mmHg Respiratory failure: Needing high-flow oxygen, non-invasive ventilation, mechanical
ventilation, or extracorporeal membrane oxygenation [ECMO] Evidence of shock: Systolic blood pressure < 90 mmHg, diastolic blood pressure
< 60 mmHg, or requiring vasopressors Significant acute renal, hepatic, or neurologic dysfunction Admission to ICU Death
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Study COV3001: Disposition and Efficacy Results
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COV3001 Disposition of Participants
Full Analysis Set (FAS)Safety Population
Per Protocol (PP)Primary Efficacy Population
Seronegative at BaselineN=39,321
*PP At Risk set: excluded participants with positive polymerase chain reaction (PCR) test for SARS-CoV-2 between vaccination and day of efficacy assessment
PP At Risk Set*Day 14: N=39,058Day 28: N=38,484
Received InjectionN=43,783
RandomizedN=44,325
Ad26.COV2.SN=21,895
N=19,630 (90%)
Day 14: N=19,514 (89%)Day 28: N=19,306 (88%)
PlaceboN=21,888
N=19,691 (90%)
Day 14: N=19,544 (89%)Day 28: N=19,178 (88%)
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COV3001: No Relevant Differences at Baseline Between Vaccine and Placebo Groups Globally
RaceAmerican Indian or Alaska Native 2,083 10% 2,060 9%Asian 743 3% 687 3%Black or African American 4,251 19% 4,264 20%Native Hawaiian or other Pacific Islander 58 0.3% 48 0.2%White 12,858 59% 12,838 59%Multiple, unknown, not reported 1,901 9% 1,989 9%
EthnicityHispanic or Latino 9,874 45% 9,963 46%
Ad26.COV2.SN = 21,895
PlaceboN = 21,888
Full Analysis Set n % n %Sex, female 9,820 45% 9,902 45%Mean Age (SD), years 50.7 (15.0) 50.7 (15.0)Age group
18-59 14,564 67% 14,547 66%≥ 60 7,331 33% 7,341 34%≥ 65 4,259 19% 4,302 20%≥ 75 809 4% 732 3%
AP-24
COV3001: Similar Baseline Demographics Between Vaccine and Placebo Groups in US
RaceAmerican Indian or Alaska Native 92 1% 95 1%Asian 655 7% 597 6%Black or African American 1,246 13% 1,264 13%Native Hawaiian or other Pacific Islander 47 0.5% 41 0.4%White 7,104 74% 7,090 74%Multiple, unknown, not reported 510 5% 558 6%
EthnicityHispanic or Latino 1,381 14% 1,454 15%
Ad26.COV2.SN = 9,655
PlaceboN = 9,647
Full Analysis Set n % n %Sex, female 4,292 45% 4,256 44%Mean Age (SD), years 53.0 (14.7) 53.2 (14.7)Age group
18-59 5,894 61% 5,870 61%≥ 60 3,761 39% 3,777 39%≥ 65 2,299 24% 2,369 25%≥ 75 445 5% 416 4%
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Full Analysis SetBaseline Comorbidity* Category, ≥ 2%
Ad26.COV2.SN = 21,895
PlaceboN = 21,888
n % n %≥ 1 risk factor 8,936 40.8% 8,922 40.8%
Obesity ≥ 30 kg/m2 6,277 28.7% 6,215 28.4%
Hypertension 2,225 10.2% 2,296 10.5%
Type 2 Diabetes Mellitus 1,600 7.3% 1,594 7.3%
Serious heart conditions 497 2.3% 511 2.3%
COV3001: Global Participants with Comorbidities Similar Between Vaccine and Placebo Groups
*Pre-existing medical risk factor for developing severe COVID-19
AP-26
Full Analysis SetBaseline Comorbidity* Category, ≥ 2%
Ad26.COV2.SN = 9,655
PlaceboN = 9,647
n % n %≥ 1 risk factor 4,227 43.8% 4,247 44.0%
Obesity ≥ 30 kg/m2 3,085 32.0% 3,054 31.7%
Hypertension 1,139 11.8% 1,166 12.1%
Type 2 Diabetes Mellitus 743 7.7% 729 7.6%
Serious heart conditions 291 3.0% 304 3.2%
Asthma 160 1.7% 203 2.1%
COV3001: US Participants with Comorbidities Similar Between Vaccine and Placebo Groups
*Pre-existing medical risk factor for developing severe COVID-19
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> Day 14 > Day 28
PP At Risk SetAd26.COV2.S
N = 19,514Placebo
N = 19,544Ad26.COV2.S
N = 19,306Placebo
N = 19,178
Number of confirmed cases, n 116 348 66 193
Person-years 3,117 3,096 3,102 3,071
Vaccine efficacy (adjusted 95% CI) 66.9%(59.0, 73.4)
66.1%(55.0, 74.8)
COV3001 Met Co-Primary Endpoints: Ad26.COV2.S Protects Against Moderate to Severe/Critical COVID-19 Globally
COV3001; confirmed: positive PCR centrally confirmed COVID-19 cases, global data
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> Day 14 > Day 28
PP At Risk SetAd26.COV2.S
N = 9,119PlaceboN = 9,086
Ad26.COV2.SN = 8,958
PlaceboN = 8,835
Number of cases, n 51 196 32 112
Person-years 1,414 1,391 1,403 1,376
Vaccine efficacy (95% CI) 74.4% (65.0, 81.6)
72.0% (58.2, 81.7)
Ad26.COV2.S Protects Against Moderate to Severe/Critical COVID-19 in US Population
COV3001; non-confirmed: all COVID-19 cases with a positive PCR from any source, regardless of central confirmation
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Kaplan Meier Shows Early Onset of Protection Against Moderate to Severe/Critical COVID-19
3
2
1
00 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126
Cumulative Incidence
%Ad26.COV2.S
Placebo
Participants at riskAd26.COV2.S 19744 19725 19669 19642 19612 19578 18541 14909 10930 7831 3998 1468 713 484 483 482 142 31 0
Placebo 19822 19804 19745 19652 19579 19488 18411 14814 10823 7740 3876 1439 708 485 482 480 133 27 0
Cumulative number of casesAd26.COV2.S 0 27 76 96 126 151 168 178 184 188 189 191 191 192 193 193 193 193 193
Placebo 0 22 81 168 237 299 351 387 407 416 423 425 430 432 432 432 432 432 432
Time to First Occurrence (days post vaccination)
Separation begins as early as Day 14
COV3001; Full Analysis Set; baseline seronegative; confirmed: positive PCR centrally confirmed COVID-19 cases
Severe cases marked as circles
AP-30
Use of Larger Dataset Justified
Cases (N)COVID-19 Case Data Set > Day 14 > Day 28 Assessment
Molecularly (PCR) confirmed by central laboratory (confirmed) 464 259 Co-primary and secondary
efficacy analyses
Global vaccine efficacy: moderate to severe/critical COVID-19 66.9% 66.1%
PCR+ test from any source, regardless of central laboratory confirmation (non-confirmed) 682 437
Subgroup analyses, COVID-19 hospitalizations, COVID-19-related deaths
Global vaccine efficacy: moderate to severe/critical COVID-19 66.3% 65.5%
Vaccine efficacy results differed between data sets by < 1% at both timepoints
High concordance (90%) between COVID-19 case datasets
COV3001
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Study COV3001: Key Secondary and Other Endpoints
Vaccine efficacy against severe/critical COVID-19 Vaccine impact on hospitalization and prevention of death Vaccine impact on asymptomatic/undetected COVID-19
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High Vaccine Efficacy Against Severe/Critical COVID-19
COV3001; confirmed: positive PCR centrally confirmed COVID-19 cases
> Day 14 > Day 28
PP At Risk SetAd26.COV2.S
N = 19,514Placebo
N = 19,544Ad26.COV2.S
N = 19,306Placebo
N = 19,178
Number of confirmed cases, n 14 60 5 34
Vaccine efficacy (adjusted 95% CI) 76.7%(54.6, 89.1)
85.4%(54.2, 96.9)
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Time to First Occurrence of Severe/Critical COVID-19 Demonstrates Early Onset of Protection
0.5
0.3
0.1
0
0.4
0.2
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126
Cumulative Incidence
%
Ad26.COV2.S
Placebo
Participants at riskAd26.COV2.S 19744 19741 19734 19725 19718 19705 18685 15043 11046 7919 4039 1481 720 490 490 489 146 31 0
Placebo 19822 19817 19799 19779 19760 19725 18682 15088 11069 7939 3995 1485 732 500 497 495 137 29 0Number of cases
Ad26.COV2.S 0 3 7 11 16 18 20 21 21 21 21 21 21 21 21 21 21 21 21Placebo 0 5 18 32 44 55 65 73 76 76 77 77 78 78 78 78 78 78 78
Time to First Occurrence (in days since vaccination)
Separation begins ~ Day 7
Day 48
COV3001; Full Analysis Set; baseline seronegative; confirmed: positive PCR centrally confirmed COVID-19 cases
AP-34
Vaccine Efficacy Against Severe/Critical COVID-19 Increased Over Time Through Day 56
COV3001; Full Analysis Set; baseline seronegative; confirmed: positive PCR centrally confirmed COVID-19 cases
0
0 7 14 21 28 35 42 49 56 63 70 77 84 91 98Time Since Vaccination (days)
Vaccine Efficacy
%
Days of follow-up 7 14 28 42 56 70 84 98% of participants with follow-up ~100% ~100% 99% 93% 55% 20% 4% 2%
100908070605040302010
Gray: 95% point-wise CI
AP-35
> Day 28
PCR+ cases from any source, regardless of central confirmation 0 16 100.0%
(74.3, 100.0)
PP At Risk SetAd26.COV2.S
Cases, nPlaceboCases, n
VE(95% CI)
> Day 14
PCR+ cases from any source, regardless of central confirmation 2 29 93.1%
(72.7, 99.2)
Data Support Substantial Effect on Prevention of COVID-19 Related Hospitalizations
COV3001; Sources: MRU (Medical Resource Utilization), SAE, and MA-COV (medical attendance-COV)Onset is earliest of either AE linked to COVID-19 or onset of COVID-19 episode following SAP algorithm
AP-36
All COVID-19 associated deaths occurred in South Africa
Ad26.COV2.S Data Support Protection Against COVID-19-Related Deaths
COV3001; non-confirmed: all COVID-19 cases with a positive PCR from any source, regardless of central confirmation
Full Analysis SetThrough January 22, 2021
Ad26.COV2.SN = 21,895
PlaceboN = 21,888
All cause mortality 3 16
COVID-19 confirmed death > Day 1 0 5
Full Analysis SetFrom January 22, 2021 to February 5, 2021
Ad26.COV2.SN = 21,895
PlaceboN = 21,888
Additional deaths reported 2 4
COVID-19 confirmed death > Day 1 0 1
*One PCR+ participant at baseline, not included
*
AP-37
Subset of Data Show Effect Against Asymptomatic/Undetected COVID-19
Per Protocol
> Day 29
VE (95%CI)Ad26.COV2.S
N = 19,630Placebo
N = 19,691
Serology Risk Set (Day 71 serology results) N = 1,346 N = 1,304
Seroconverted SARS-CoV-2 (Day > 29)a 18 50 65.5% (39.9, 81.1)
Seroconverted SARS-CoV-2 without previous symptoms (Day > 29)a,b 10 37 74.2% (47.1, 88.6)
a Serologically converted: positive serology (Non-S protein) test without SARS-CoV-2 positive RT-PCR before positive serology test irrespective of previous symptomsb Without previous symptoms: no COVID-19 symptoms occurred before positive serology test at any point during study
AP-38
Study COV3001: Additional Analyses
Vaccine efficacy by prespecified subgroups Vaccine efficacy by countries with emerging variants
AP-39
Overall VE Against Moderate to Severe/Critical COVID-19 Consistent Across Prespecified Subgroups
COV3001; global; non-confirmed: all COVID-19 cases with a positive PCR from any source, regardless of central confirmation
# Events / N > Day 28
Per Protocol Ad26.COV2.S
N = 19,630Placebo
N = 19,691Moderate to
Severe/Critical COVID-19Vaccine Efficacy
(95% CI)PP Risk Set 113 / 19,306 324 / 19,178 65.5% (57.2, 72.4)Age
18 – 59 years 87 / 12,617 259 / 12,527 66.8% (57.5, 74.3)≥ 60 years 26 / 6,689 65 / 6,651 60.4% (36.8, 75.9)
Participants with comorbidities (all ages)Yes 44 / 7,684 105 / 7,626 58.6% (40.6, 71.6)No 69 / 11,622 219 / 11,552 68.8% (59.0, 76.6)
SexMale 54 / 10,764 176 / 10,649 69.8% (58.9, 78.2)Female 59 / 8,538 148 / 8,525 60.3% (46.0, 71.2)
Race and ethnicityNon-Hispanic / Latino 52 / 10,131 163 / 9,957 68.8% (57.2, 77.6)Hispanic / Latino 59 / 8,688 153 / 8,741 61.3% (47.4, 71.8)White 64 / 11,994 187 / 11,912 66.2% (54.8, 74.9)Black 21 / 3,330 66 / 3,300 68.6% (48.0, 81.8)
-25 0 25 50 75 100VE% (95% CI)
AP-40
# Events / N > Day 28Country
% Variant SeverityAd26.COV2.S
N = 19,306Placebo
N = 19,178Vaccine Efficacy
(95%CI)United States
96% D614G3% CAL.20C
Moderate-Severe/Critical 32 / 8,958 112 / 8,835 72.0% (58.2, 81.7)
Severe/Critical 1 / 8,958 7 / 8,835 85.9% (-9.4, 99.7)
Brazil69% P.2 lineage31% D614G
Moderate-Severe/Critical 24 / 3,354 74 / 3,312 68.1% (48.8, 80.7)
Severe/Critical 1 / 3,354 8 / 3,312 87.6% (7.8, 99.7)
South Africa95% B.1.351 lineage 3% D614G
Moderate-Severe/Critical 23 / 2,449 64 / 2,463 64.0% (41.2, 78.7)
Severe/Critical 4 / 2,449 22 / 2,463 81.7% (46.2, 95.4)
Vaccine Efficacy Consistently High Across Key Countries > Day 28
COV3001; non-confirmed: all COVID-19 cases with a positive PCR from any source, regardless of central confirmation *Sources: MRU (Medical Resource Utilization), SAE, and MA-COV (medical attendance-COV); **6th case excluded due to PCR+ test at baseline
VE% (95% CI)-25 0 25 50 75 100
South Africa PP At Risk Set (N = 4,912) Hospitalizations > Day 28*: 0 vs 6 (Ad26.COV2.S vs placebo)Full Analysis Set (N = 6,576) COVID-related deaths: 0 vs 5** (Ad26.COV2.S vs placebo)
AP-41
85% VE* against severe disease Onset of protection as early as 7 days after vaccination Complete protection against COVID-19 related hospitalizations* and deaths
66% VE* against moderate to severe disease across all countries Onset evident as early as Day 14, and increased through Day 56
72% VE* against moderate to severe COVID-19 in US Study participants reflected the diversity of the overall US population
Protection against all symptomatic disease consistent with primary endpoint High-quality, robust data at a time when the incidence of SARS-CoV-2 was increasing,
and new, highly transmissible variants were emerging High levels of protection consistent across subgroups, countries and regions*
Single Dose of Ad26.COV2.S Offers Substantial Protection Against COVID-19
*> Day 28
AP-42
Study COV3001: Safety Results
AP-43
COV3001 Safety Subset Includes Data on Solicited and Unsolicited Adverse Events
Received InjectionN=43,783
RandomizedN=44,325
Ad26.COV2.SN=21,895
N=3,356 (15%)
PlaceboN=21,888
N=3,380 (15%)
Full Analysis Set (FAS)Safety Population
Analysis of SAEs, MAAEs, AEs leading to disc., deaths
Safety SubsetAnalysis of solicited and
unsolicited AEs(N=6,736)
Safety analysis cut off date: January 22, 2021
AP-44
Median follow up after vaccination was 58 days Full Analysis Set: 55% had ≥ 2 months of follow-up Safety Subset: nearly all (99.9%) completed post-vaccination
period of Day 1-29
Safety Data Met FDA Guidelines for Median Follow-Up of At Least 2 Months
COV3001; safety analysis cut off date: January 22, 2021
AP-45
Study COV3001: Solicited Adverse Events
AP-46
≥ 1 Local AEInjection Site
PainInjection Site
ErythemaInjection Site
Swelling
Local Adverse Events, Nearly All Grade 1 and 2 in Severity, All Events Resolved 2-3 Days After Injection
0%
20%
40%
60%
80%
100%
≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60
Grade 1
Grade 2
Grade 3Ad26.COV2.S
0%
20%
40%
60%
80%
100%
≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60
Placebo
COV3001; Safety Subset
0.9%
0.4%
0.4%
0.2%
0.2%0.2%0.1%0.3%
0.2% 0.2% 0.2%0.1%0.1%
AP-47
≥ 1 AE Fatigue Headache Myalgia Nausea Fever
Systemic Adverse Events Transient with Median Duration of 1-2 Days
0%
20%
40%
60%
80%
100%
≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60
Grade 1Grade 2Grade 3
Ad26.COV2.S
0%
20%
40%
60%
80%
100%
≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60 ≥ 18 to 59 ≥ 60
Placebo
COV3001; Safety Subset
2.3%
1.1% 1.2%0.8%
0.9%
0.4%1.4%
0.1%0.3%0.2%0.1%
0.2%
0.6% 0.7%0.2% 0.4% 0.2% 0.3%
<0.1% 0.2%0.1%0.4%
AP-48
Study COV3001: Unsolicited Adverse Events
AP-49
Similar Rates of Unsolicited AEs Between Groups
Ad26.COV2.S PlaceboUnsolicited Adverse Events n % n %Safety Subset N = 3,356 N = 3,380
Any Adverse Event (AE) 440 13% 407 12%
Full Analysis Set (FAS) N = 21,895 N = 21,888
Any Medically-Attended Adverse Event (MAAE) 304 1.4% 408 1.9%
Any Serious Adverse Event (SAE) 90 0.4% 137 0.6%
Not COVID-19-related SAE 83 0.4% 96 0.4%
Any death (reported through January 22, 2021) 3 <0.1% 16 0.1%
COVID-19 related deaths 0 - 5* -
COV3001; *Excludes PCR+ participant at baseline
AP-50
Other Adverse Events of Interest
Full Analysis Set
Ad26.COV2.SN = 21,895
PlaceboN = 21,888
n nHypersensitivity* 77 65
Venous thromboembolic events** 14 10
Convulsions 4*** 1
Tinnitus 6 0
Peripheral neuropathy 2 2
Guillain-Barre Syndrome 1 1
Bell’s Palsy 3 2
COV3001*No anaphylaxis
**Most participants had relevant predisposing medical conditions and/or other factors***Three participants with history of epilepsy, one additional event followed transverse sinus thrombosis
AP-51
Thrombotic and Thromboembolic Events
COV3001* 2 events occurred in one participant
Full Analysis Set
Ad26.COV2.SN = 21,895
PlaceboN = 21,888
n nTotal participants with any event 14 10
Venous thromboembolic eventsDeep vein thrombosis 6 2Pulmonary embolism 4 1Transverse sinus thrombosis 1 0Thrombosed hemorrhoid 0 1
Total participants with venous events 11 4
Arterial thromboembolic eventsCerebrovascular events 3* 3Cardiovascular events 1 3
Total participants with arterial events 3 6
AP-52
Demonstrated acceptable safety and reactogenicity profile Overall, reactogenicity mild and transient Grade 3 reactogenicity rare
Most AEs mild or moderate Generally resolved 1 to 2 days post vaccination
Safety further supported by > 193,000 individuals exposed to Janssen Ad26-based vaccines
Benefits of Ad26.COV2.S Outweigh Known and Potential Risks
AP-53
Upon authorization by a regulatory authority, all placebo participants to receive 1 dose of Ad26.COV2.S
All participants encouraged to remain in study up to 2 years to assess efficacy, safety, immunogenicity
Amendment will allow assessment of Duration of protection and immunogenicity of single dose
by comparing 2 groups vaccinated ~4-6 months apart
COV3001 Protocol Amendment to Facilitate Cross-Over of Placebo Participants
AP-54
Overview of Janssen’s Single-Dose COVID-19 Vaccine, Ad26.COV2.SJanssen Pharmaceutical Companies of Johnson & Johnson
US Centers for Disease Control and PreventionAdvisory Committee on Immunization Practices February 28, 2021
